Radiographic Fusion Results for the ACDF Subjects

Fusion Status
Investigational Device Exemption (IDE) Study
6M 42/94
(44.7%)
12M 58/92
(63.0%)
24M 77/96
(80.2%)
36M 73/84
(86.9%)
48M 74/86
(86.0%)
Post Approval Study (PAS)
60M 70/81
(86.4%)
84M 60/66
(90.9%)

Radiographic Fusion Results for the ACDF Subjects

Fusion Status
Investigational Device Exemption (IDE) Study
6M 42/69
(60.9%)
12M 58/70
(82.9%)
24M 67/75
(89.3%)
36M 57/63
(90.5%)
48M 58/62
(93.5%)
Post Approval Study (PAS)
60M 56/60
(93.3%)
84M 47/49
(95.9%)